Prevention of Diabetic Foot Clinical Trial
— BIONEDIANOfficial title:
Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus
| NCT number | NCT04257409 |
| Other study ID # | 546417 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | January 1, 2021 |
The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very
often given by biomechanical abnormalities frequently present in those patients. The aim of
our randomized controlled study is to find possible changes as of plantar pressures as of
biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with
different degrees of neuropathy. During this project, investigators will examine the possible
impact of 12-week lasting intervention program on the distribution of plantar pressures,
joint mobility and muscle strength of lower limbs. The incidence of ulcerations /
reulcerations and changes of psychosocial characteristics will be evaluated during the study
period.
Approximately 60 patients with Type 2 diabetes mellitus will be included into the study.
These patients will be randomized into 3 study groups - patients with type 2 DM with mild
form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral
neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20
subjects). All patients will undergo 12 week lasting active intervention program consisting
of recommendations by a physiotherapist focusing on the improvement of physical fitness,
muscle strength and foot joint improvement. Control group will be consisted of 20 patients
with healed diabetic foot.
The outcomes of this project will try to objectively verify in the randomized controlled
trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality
of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot
syndrome.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | March 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes mellitus - sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results) - diabetic foot with healed diabetic foot ulcers, inactive Charcot foot Exclusion Criteria: - impossibility to exercise - amaurosis - non-compliance - critical limb ischemia - active ulcer, surgical wound - active Charcot foot - active carcinoma - recent stroke (last 8 weeks) - recent myocardial infarction (last 8 weeks) - recent PTA, PCI, bypass (last 8 weeks) - myopathy - rheumatoid arthritis - cox-, gonartrosis of 3rd -4th grade. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Institute for Clinical and Experimental Medicine | Prague |
| Lead Sponsor | Collaborator |
|---|---|
| Mgr. Eliška Vrátná | prof. Ing. Václav Bunc, CSc, Vladimíra Fejfarová, MD, PhD |
Czechia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Biomechanics- plantar pressures | plantar pressures will be evaluated by pedobarograph (in Newtons) | changes after 12 weeks, 24 weeks | |
| Primary | Biomechanics- biomechanics of the ankle | biomechanics of the ankle will be assessed by goniometry in angles | changes after 12 weeks, 24 weeks | |
| Primary | Biomechanics- changes of foot joint angles | changes of foot joint agles will be evaluated by measurement of X-Rays bones angles - calcaneal pitch, talar-1st metatarsal angle and lateral Talocalcaneal angle | changes after 12 weeks, 24 weeks | |
| Primary | Fitness - physical activity | The amount of physical activity will be assessed by IPAQ questioners | changes after 12 weeks, 24 weeks | |
| Primary | Fitness - muscle strength | Muscle strength will be measured by dynamometry in Newtons | changes after 12 weeks, 24 weeks | |
| Primary | Fitness - senior fitness | fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds) | changes after 12 weeks, 24 weeks | |
| Secondary | ulceration/reulceration | detection of the incidence of ulceration/reulceration | changes after 12 weeks, 24 weeks | |
| Secondary | Psychosocial changes - quality of life | Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings | changes after 12 weeks, 24 weeks | |
| Secondary | Psychosocial changes - depression | Depression status will be asessed by Geriatric Depression Scale (GDS) scale - minimum 0, maximum 30 points (higher then 9 points- mild form of depression, higher then 20 - severe depression | changes after 12 weeks, 24 weeks | |
| Secondary | Psychosocial changes - stress readaptation | Adaptation to stress will be detected by Stress Readaption Scale (0-400 points) - points higher then 150 - higher risk of worse stress readaptation and therefore higher risk of somatisation | changes after 12 weeks, 24 weeks | |
| Secondary | Metabolism - glucose control | Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l) | changes after 12 weeks, 24 weeks | |
| Secondary | Metabolism - lipid profile | The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l) | changes after 12 weeks, 24 weeks | |
| Secondary | Metabolism - myokines | Patients will be checked for changes in selected cytokines nad myokines (IL-4,6,7,8,15 in pg/ml, myostatin in pg/ml, irisin in ng/ml, FGF-21 in pg/ml) | changes after 12 weeks, 24 weeks |